Senior Manager / Manager, Development Operations Optimization

JOB TITLE: Manager/Senior Manager, Clinical Development Operations Optimization

DEPARTMENT: Development Operations

HIRING MANAGER: Lorna Dean

LOCATION: South San Francisco, California / Remote

TYPE: Full-Time

HI-Bio is a clinical stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. We have a precision medicine approach grounded in emerging human genetics. HI-Bio's team is made up of industry experts from science and technology. We are on a path to building the leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.

We are seeking a Manager/Senior Manager Development Operations Optimization to manage the execution of Clinical Trial related activities at HI-Bio. The successful candidate will be able to execute their duties with minimal guidance/supervision while ensuring alignment with GCP and HI-Bio's SOPs. As our portfolio and programs mature and advance, this person will impact our ability to initiate, monitor, and organize clinical trials quickly and accurately. The role is highly collaboration focused and will work with other development teams to implement new tools, processes, and other solutions to address current and future challenges. Our ideal candidate will have ample experience in clinical development operations and will have a desire to oversee tactics and methods to improve clinical trial efficiency and accuracy.

KEY RESPONSIBILITIES:

• Support and/or manage clinical study planning deliverables for a study or program, including milestone tracking, timelines and dashboards

• Business process owner of trial master file (TMF) and all related processes and TMF study related activities. Oversight of TMF related staff/resources.

• Manage supplier related activities for TMF and other suppliers within span on control

• Monitor and track planning milestones of studies, help identify study related trends/issues and work with Clinical Study Team to gather and maintain current information.

• Attend and contribute to supplier meetings, work with suppliers to resolve issues, and foster process improvements.

• Design and manage training material, Quick Reference and FAQ logs for areas of responsibility

• Develop and manage controlled documentation supporting areas of responsibility.

• Participate on the clinical study teams

• Support and contribute to Inspection Readiness processes.

• May participate in cross-functional process improvement initiatives.

• May lead and/or participate in User Acceptance Testing (UAT) with supplier systems.

• Contribute to various clinical operations and development operations process deliverables.

EDUCATION AND QUALIFICATIONS:

• Combination of degree and relevant Biopharma related experience within a pharmaceutical,

biotech environment or other relevant experience.

• • Doctorate degree and 2 years of direct related experience

or

• • Master's degree and 6 years of direct related experience

or

• • Bachelor's degree and 8 years of direct related experience

and

• • 2 years direct experience in a Development Operations related function/role

• Demonstrated experience in successfully managing study timelines, vendors, and other tracking.

• High attention to detail and an ability to find potential gaps and implement solutions.

• Experience in immunology is a plus; experience in a lean, small company is a plus.

• Strong written and verbal communication.

• Current and abreast knowledge of emerging trends, systems, processes, and regulatory requirements as it relates to clinical trial administration.

• Experience designing training materials, SOPs, and new process initiatives is highly desired.

• Ability to adapt and work in a fast-paced environment.

• A "can-do" disposition and an innate desire to refine activities.

• Ability to travel up to 30%, which may vary on study and other timelines.

HI-BIO RECRUITING:

HI-Bio, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.